Dépistage unitaire simutané des génomes des virus de l'immunodéficience humaine et de l'hépatite C en transfusion : essai d'un test sur un système semi-automatique

Abstract

Nucleic acid testing (NAT) of human immunodeficiency virus (HIV) and hepatic C virus (HCV) will decrease the serologic window period in about 11 days for HIV and 31 days for HCV. In field of NAT and in aim to introduce the HIV and HCV RNAs screening in transfusion, we have evaluated a new test, the Multiplex ® TMA, HIV1/HCV RNA (Gen-Probe-Chiron, USA), a test based on transcription mediated amplification technology which detects simultaneously HIV1 and HCV RNAs. Donor's plasma are collected on a special tube with a gel barrier (PPT, BD Vacutainer ®). An initial reactive sample (IR) has been controlled in duplicate. Only the repeat reactive samples (RR) are evaluated with a discriminant test HIV1 or HCV RNA. Sensitivity was estimated with panels (Pelicheck HIV and HCV, CLB, Amsterdam, NL) and fidelity with a multimarker run control (Pelispy, CLB, Amsterdam, NL). On 29,593 donor's samples, 67 are IR (0.22%). After control, two (0.007%) are RR. One is HCV RNA positive and the other HIV1 RNA positive. Each sample is positive for anti-HCV or anti-HIV1 antibodies respectively. With Pelicheck HIV1 RNA subtype B, a positive result in duplicate is observed up to a concentration of 8 HIV1 RNA genome equivalents/mL (geq/mL). On Pelicheck HCV RNA genotype 3 and HCV RNA 1997 genotype 1, 140 HCV RNA geq/mL and 9 HCV RNA geq/mL are detected respectively. In and between assays coefficients of variation are between 2.0% and 6.0% for the first and 8.0% for the second with the multimarker run control. This study shows that the Multiplex ® TMA HIV1/HCV RNA has a very good sensitivity and specificity as it does in fidelity. NAT can be routinely performed in single with this test in transfusion.